BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 MM HI-FI TAPE

    MDR report key: 25019814 · Received April 28, 2026

    Report

    Report Number
    3009681798-2026-00018
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 28, 2026
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    UDI-DI
    10653405005476
    PMA / PMN Number
    K153307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR EVALUATION AND THE LABELING ISSUE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. THERE WERE NO NONCONFORMITIES WITH THE RAW MATERIAL USED. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THIS LOT WAS MANUFACTURED IN OCTOBER OF 2022, AND AT THAT TIME THE LABELING ON THE BOX MET THE REQUIREMENTS OF THE LABEL AND CUSTOMER SPECIFICATIONS. 1DZ OF LOT 22100328 REMAINED IN INVENTORY AND WAS NOT SCRAPPED AT THE TIME THE NEW LABELING REQUIREMENTS WENT INTO EFFECT. THIS REMAINING BOX WAS SHIPPED ON (B)(6) 2026, AND ALTHOUGH LABELING REQUIREMENTS WERE MET WHEN IT WAS MANUFACTURED, THE LABELS DID NOT MEET THE REQUIREMENTS AT THE TIME THAT IT WAS SHIPPED. ALL FINISHED GOODS AT THE TIME OF THE CHANGE WERE TO BE USED AS IS, THEREFORE THIS PRODUCT WAS TO BE ACCEPTED. HOWEVER, FIFO WAS NOT FOLLOWED, CAUSING A BOX WITH OLD LABELING TO BE SHIPPED AFTER MANY SHIPMENTS OF BOXES WITH NEW LABELS. THERE IS NO INVENTORY OF THIS PRODUCT ON HAND AT THE TIME OF THIS COMPLAINT, AND NO OTHER LOTS MANUFACTURED PRIOR TO THE LABELING CHANGE HAVE BEEN SHIPPED AFTER THE IMPLEMENTATION OF SAID CHANGE. THIS IS AN ISOLATED INSTANCE AND ALL AFFECTED PRODUCT HAS BEEN RETURNED FROM THE DISTRIBUTOR. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "PLEASE SEE BELOW FOR DETAILS OF NONCONFORMANCE IDENTIFIED AT INSPECTION. THIS NOTIFICATION IS STRICTLY FOR DOCUMENTATION PURPOSES. RMA FOR THE INDIVIDUAL BOX (QTY: 12) HAS BEEN RECEIVED. REST OF LOT WILL GO TO STOCK AND 1 UNIT WILL BE RETURNED. 1 BOX OF 12 RECEIVED WITH WRONG ARTWORK ON LABEL. LOT # 22100328."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173362 2 MM HI-FI TAPE 39" (99CM) BLUE HI-FI UHMWPE CO-BRAID GAT RIVERPOINT MEDICAL LLC HT7110 22100328 10653405005476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown